Treatment for Heart Failure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mayo Clinic in Rochester, Rochester, MN
Heart Failure+4 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new drug can improve kidney function and hormonal function in patients with heart failure and kidney dysfunction.

See full description

Eligible Conditions

  • Heart Failure
  • Cardiorenal Disease
  • Renal Disfunction

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 6 secondary outcomes in patients with Heart Failure. Measurement will happen over the course of baseline to 3 weeks.

3 weeks
Number of Subjects with Hypotension
baseline to 3 weeks
Change in Blood Pressure
Change in Glomerular Filtration Rate
Change in Renin-angiotensin-aldosterone system (RAAS)
Change in Sodium Excretion
Change in Urine Annexin A1 (AnxA1) Protein Levels
Change in Urine Flow

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Placebo first, then ANX-042
1 of 2
ANX-042 first, then Placebo
1 of 2
Active Control

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Placebo first, then ANX-042In the first intervention period the subjects will receive placebo. There will be a 3 week washout period. In the second intervention period, the subjects will receive an infusion of ANX-042.
ANX-042 first, then PlaceboIn the first intervention period the subjects will receive an infusion of ANX-042. There will be a 3 week washout period. In the second intervention period, the subjects will receive an infusion of placebo

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 weeks for reporting.

Who is running the study

Principal Investigator
P. M. M. M.
Paul M. McKie M.D., PI
Mayo Clinic

Closest Location

Mayo Clinic in Rochester - Rochester, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Left ventricular ejection fraction of equal or less than 40% assessed by echocardiography, nuclear scan, MRI or left ventriculogram within the past 48 months. If assessment is greater than 12 months old, hand-held echocardiogram (ECHO) determination will be performed at consent visit once enrolled.
Stable New York Heart Association (NYHA) class II and III symptoms as defined by: no change in NYHA symptoms over the past 3 months, on stable doses of furosemide, angiotensin-converting enzyme (ACE) inhibitor or angiotensin II type 1 (AT1) blocker, beta blocker, or aldosterone antagonist over the last 4 weeks and no episode of decompensated Congestive Heart Failure (CHF) over the past 6 months.
Calculated creatinine clearance of equal or less than 70 ml/min and greater than 20 ml/min, using the Modification of Diet in Renal Disease (MDRD) formula assessed within the past 48 months and a confirmatory calculated creatinine clearance equal or less than 70 ml/min and greater than 20 ml/min at the time of enrollment.
Digoxin, antiarrhythmic medications and other vasodilators will be allowed; however, all medications must be at stable doses 4 weeks prior to enrollment. Subjects taking non-steroidal anti-inflammatory drugs (NSAIDs), except aspirin, will not be able to increase their medication dose for the duration of the study.

Patient Q&A Section

How many people get kidney failure a year in the United States?

"around 30 million US adults have kidney failure, or around one in ten of US adults have a kidney disease. This is the highest incidence of kidney disease of any country." - Anonymous Online Contributor

Unverified Answer

What is kidney failure?

"Kidney failure is a disease state that disrupts water reabsorption in the kidneys. As a result, kidney failure can lead to a decrease in proper bodily function. In patients with end stage kidney failure, the chance to receive a kidney transplant is extremely low.\n" - Anonymous Online Contributor

Unverified Answer

What causes kidney failure?

"The causes of kidney failure are numerous, and their etiologies are complex in both cause and mechanism. Most kidney failure is a result of loss of kidney function, usually secondary to renal disease but also from non-renal causes such as congestive heart failure, infections and high volumes of fluid in a person's body (polysugar/lipomania). Most people with kidney failure do not have kidney failure, and most with chronic kidney failure (requiring dialysis or transplants) never require treatment beyond the condition that triggered kidney failure. Most kidney failure in children and adolescents is secondary to renal disease, but in other age groups it is primarily a consequence of kidney disease." - Anonymous Online Contributor

Unverified Answer

What are common treatments for kidney failure?

"Treatment of chronic kidney failure typically involves medications (e.g. oral medication), dialysis, [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant)ation or lung-kidney transplantation. While this article does not highlight all treatments for kidney failure, the treatment options included in this review should help physicians and patients with chronic kidney failure in their choice of management." - Anonymous Online Contributor

Unverified Answer

Can kidney failure be cured?

"Recent findings is limited by its cross-sectional design and its choice of measures; a prospective study using more detailed and standardized measures as well as multivariable analyses is warranted. Nevertheless, these results demonstrate that dialysis does not cure the illness or lead to better QoL, and that dialysis may even be detrimental." - Anonymous Online Contributor

Unverified Answer

What are the signs of kidney failure?

"All kidney failure patients should have a blood test every 2 months, and a urinalysis every 3 months for signs of worsening kidney failure. Dialysis is a lifelong treatment for patients who are reliant on dialysis. Patients should also be checked on for risk of malnutrition, infection and other complications. This may include checking blood for anaemia, C-reactive protein, parathyroid hormone level, electrolytes and renal function, and checking medications used to treat blood pressure (anti-diabetic, anti-hypertensive and statin). It is very important to check on renal function frequently in dialysis patients and if worsening it may advise for more frequent blood tests such as every 2 months over the first 3 months of dialysis." - Anonymous Online Contributor

Unverified Answer

Has treatment proven to be more effective than a placebo?

"Treatment seems to reduce the progression rate of CKD and mortality in patients with chronic kidney disease with a primary renal disease. Results from a recent paper of this observational analysis need to be validated in a randomized trial." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating kidney failure?

"Despite significant improvements in prevention, treatment, and management, the outcome for patients and their family members remains unsatisfactory. Currently, our therapies are highly specialized, and they are targeted at a small subset of all patients suffering from chronic kidney disease. A comprehensive multi-disciplinary approach to the treatment of chronic kidney disease is recommended." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of kidney failure?

"Of the 25 cases of kidney failure, 4 were attributed to obstructive uropathy [congenital urinary tract malformations (n = 3) and unknown cause (n = 1)]: 6-7 times more common in males than in females. In conclusion, the aetiology of kidney failure in this cohort of patients is similar to that of other groups. Recent findings has shown that individuals with a family history of kidney failure are more likely to develop complicated non-infective kidney disease than those with no prior history. Further research is required to identify the genetic predisposition that increases one's risk of developing complicated kidney diseases or if there are any other factors which could influence disease progression." - Anonymous Online Contributor

Unverified Answer

How serious can kidney failure be?

"Some patients in our institution had fairly mild to severe kidney failure, whereas some others had a very poor outcome. However, there is no simple way to predict outcomes, so [information about the type, severity, and location of kidney failure should be present in [power (aafp.org/)(aafp.org/)]." - Anonymous Online Contributor

Unverified Answer

What is treatment?

"There is no standard definition or treatment for people with chronic kidney disease (CKD) who also have kidney failure. Most CKD guidelines recommend the use of the MDRD equation for estimating serum creatinine concentration. However, the MDRD equation is flawed with people who have an 'altered' CKD profile including non-functioning kidney, CKD in the early stages before or during dialysis, as well as in the elderly. These people are at risk of poor outcome and deserve adequate monitoring and treatment at a nephrology unit (Nephro)." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving treatment?

"There has been one large trial evaluating kidney-secretory protein treatment in kidney failure. The main question this trial sought to answer was whether the treatment led to an increase in survival. The authors concluded that the treatment did not lead to increased survival or increased length of stay in the hospital." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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