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Diuretics for Heart Failure (MsDR 2 Trial)

Q: What is the aggregate amount of individuals who have consented to take part in this research?

Affirmative. According to the information on clinicaltrials.gov, this research is ongoing and accepting applications from participants. The study was initiated on April 21st 2023 and last modified on May 1st 2023. A total of 50 individuals will be admitted at a single site for this trial.

Q: Has Bendrofluomethiazide/ Amiloride been sanctioned by the FDA?

Due to the limited supporting data, Bendroflumethiazide/ Amiloride received a safety rating of 1 on our team's scale. This medication is currently in Phase 1 trials and is yet to be fully evaluated for efficacy and safety.

Q: Are there any openings currently available for participants of this investigation?

Affirmative, the data hosted on clinicaltrials.gov indicates that this medical experiment is presently seeking participants and was first made available to potential candidates on April 21st 2023. The latest update to the trial's information occurred on May 1st 2023 with 50 patients needed from a single medical centre.

Phase 1

Recruiting

Led By Jeffrey Testani

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18 years

Chronic clinical diagnosis of HF with a documented ejection fraction <40%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 21 days

Awards & highlights

MsDR 2 Trial Summary

This trial tested 4 combinations of placebo & drugs to treat edema.

Who is the study for?

This trial is for adults over 18 with heart failure and an ejection fraction below 40%. They should be on stable doses of certain heart medications, have no recent hospitalizations, and not plan to change their medication during the study. People with very low kidney function, recent use of other diuretics (except low-dose aldosterone antagonists), or those who are pregnant can't participate.Check my eligibility

What is being tested?

The study tests how well different combinations of drugs help people whose bodies resist water pills (diuretics) in heart failure. It compares Bendroflumethiazide and Amiloride—both added to Bumetanide—with a placebo in a randomized, controlled manner where neither doctors nor patients know who gets which treatment.See study design

What are the potential side effects?

Possible side effects include changes in blood electrolytes like potassium or sodium levels that could affect the heart rhythm, dehydration due to increased urine production from diuretics, dizziness or lightheadedness especially upon standing up quickly.

MsDR 2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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My heart's pumping ability is less than 40%.

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I haven't been hospitalized in the last 3 months.

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I have been taking 80mg or more of a water pill daily for at least 30 days.

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My kidney responded to a specific water pill test with less salt in my urine than usual.

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I've been on stable heart medication doses for 30 days without plans to change.

MsDR 2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~21 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in distal sodium reabsorption

Change in peak FENa from bumetanide monotherapy to bumetanide plus combination therapy

Correlation between distal sodium reabsorption and uEV pendrin/CD9

MsDR 2 Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Bendroflumethiazide/ AmilorideActive Control2 Interventions

This study will employ a randomized placebo-controlled, double-blind, double-dummy, crossover design testing combinations placebo/placebo, bendroflumethiazide/placebo, amiloride/placebo, and bendroflumethiazide/amiloride added to bumetanide on Days 0, 7, 14 and 21

Group II: Placebo/ AmilorideActive Control2 Interventions

Group III: Placebo/ BendroflumethiazideActive Control2 Interventions

Group IV: Placebo/ PlaceboPlacebo Group1 Intervention

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,848 Previous Clinical Trials

2,737,768 Total Patients Enrolled

32 Trials studying Heart Failure

55,949 Patients Enrolled for Heart Failure

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,358 Previous Clinical Trials

4,315,191 Total Patients Enrolled

6 Trials studying Heart Failure

378 Patients Enrolled for Heart Failure

Jeffrey TestaniPrincipal InvestigatorYale University

1 Previous Clinical Trials

75 Total Patients Enrolled

1 Trials studying Heart Failure

75 Patients Enrolled for Heart Failure

Media Library

Bendroflumethiazide/ Amiloride Clinical Trial Eligibility Overview. Trial Name: NCT05753059 — Phase 1

Heart Failure Research Study Groups: Bendroflumethiazide/ Amiloride, Placebo/ Amiloride, Placebo/ Bendroflumethiazide, Placebo/ Placebo

Heart Failure Clinical Trial 2023: Bendroflumethiazide/ Amiloride Highlights & Side Effects. Trial Name: NCT05753059 — Phase 1

Bendroflumethiazide/ Amiloride 2023 Treatment Timeline for Medical Study. Trial Name: NCT05753059 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate amount of individuals who have consented to take part in this research?

"Affirmative. According to the information on clinicaltrials.gov, this research is ongoing and accepting applications from participants. The study was initiated on April 21st 2023 and last modified on May 1st 2023. A total of 50 individuals will be admitted at a single site for this trial."

Answered by AI

Has Bendrofluomethiazide/ Amiloride been sanctioned by the FDA?

"Due to the limited supporting data, Bendroflumethiazide/ Amiloride received a safety rating of 1 on our team's scale. This medication is currently in Phase 1 trials and is yet to be fully evaluated for efficacy and safety."

Answered by AI

Are there any openings currently available for participants of this investigation?

"Affirmative, the data hosted on clinicaltrials.gov indicates that this medical experiment is presently seeking participants and was first made available to potential candidates on April 21st 2023. The latest update to the trial's information occurred on May 1st 2023 with 50 patients needed from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mechanisms of Diuretic Resistance in Heart Failure, Aim 2

Jeffrey Testani 2023. "Mechanisms of Diuretic Resistance in Heart Failure, Aim 2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05753059.