120 Participants Needed

MANP for High Blood Pressure

(BOLD-HTN Trial)

Recruiting at 20 trial locations
SR
LG
LT
AJ
DB
ST
DS
Overseen ByDanny Sugimoto, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: E-Star BioTech, LLC
Must be taking: Antihypertensives, Diuretics, ACEi or ARB
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a Phase 2 dose-titration study designed to evaluate the safety and efficacy of MANP subcutaneous injection compared to placebo in reducing baseline daytime systolic blood pressure (SBP), derived from 24-hour ambulatory blood pressure monitoring (ABPM), in subjects with hypertension who are taking 3 or more antihypertensive medications with different mechanisms of action.

Do I need to stop my current medications for the trial?

The trial does not specify that you need to stop your current medications. In fact, you must be taking at least three different blood pressure medications to participate.

Is MANP safe for humans?

Research on atrial natriuretic peptides, including MANP, shows they can lower blood pressure and have beneficial effects on the heart and kidneys. However, a mutation in the peptide has been linked to atrial fibrillation (irregular heartbeat) in some people, indicating potential safety concerns that need further investigation.12345

How is the drug MANP different from other high blood pressure treatments?

MANP is unique because it activates a specific receptor (pGC-A) that helps lower blood pressure and enhances kidney function, while also reducing the production of aldosterone, a hormone that can raise blood pressure. This makes it different from other treatments that may not target these specific pathways.26789

What data supports the effectiveness of the drug MANP for high blood pressure?

Research shows that MANP, a type of atrial natriuretic peptide, can lower blood pressure and improve kidney function in animal models of high blood pressure. It also reduces the production of aldosterone, a hormone that can increase blood pressure, suggesting it may be effective in treating high blood pressure in humans.256810

Who Is on the Research Team?

DS

David Smith, MD

Principal Investigator

E-Star BioTech, LLC

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with resistant hypertension, taking three or more blood pressure medications including a diuretic and an ACEi/ARB. They must have a certain level of kidney function (eGFR ≥ 30 mL/min/1.73m2), not be able to bear children or agree to use contraception, and have specific high blood pressure readings.

Inclusion Criteria

My kidney function, measured by eGFR, is between 20-30 ml/min/1.73m^2.
I am not able to become pregnant.
My kidney function, measured by eGFR, is at least 30.
See 4 more

Exclusion Criteria

I am on dialysis or have had a kidney transplant.
Subjects who are pregnant or breastfeeding
My cancer was diagnosed or came back in the last 3 years.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous MANP or placebo once daily for 42 days to evaluate safety and efficacy in reducing systolic blood pressure

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and metabolic biomarkers

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • MANP
Trial Overview The study tests MANP injections against placebo in lowering daytime systolic blood pressure in patients with difficult-to-control hypertension. It's a Phase 2 trial where doses are adjusted over time while monitoring the effects using ambulatory blood pressure measurements.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: MANPActive Control1 Intervention
Group II: Placebo-matched controlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

E-Star BioTech, LLC

Lead Sponsor

Trials
2
Recruited
160+

PPD

Industry Sponsor

Trials
162
Recruited
36,600+
Dr. Austin Smith profile image

Dr. Austin Smith

PPD

Chief Medical Officer since 2020

Doctor of Medicine from the Royal College of Surgeons in Ireland

David Simmons profile image

David Simmons

PPD

Chief Executive Officer since 2012

Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University

Mayo Clinic

Collaborator

Trials
3,427
Recruited
3,221,000+

PPD DEVELOPMENT, LP

Industry Sponsor

Trials
167
Recruited
38,000+
David Simmons profile image

David Simmons

PPD DEVELOPMENT, LP

Chief Executive Officer since 2012

BSc in Applied Science from Georgia Institute of Technology

Martina Flammer profile image

Martina Flammer

PPD DEVELOPMENT, LP

Chief Medical Officer since 2024

MD

PPD Development, LP

Industry Sponsor

Published Research Related to This Trial

In a study of 43 subjects with essential hypertension, plasma levels of atrial natriuretic polypeptide (ANP) were significantly higher compared to those with borderline hypertension and normotensive controls, indicating a potential role of ANP in hypertension.
Effective antihypertensive therapy led to a significant reduction in plasma ANP levels after 4 weeks, suggesting that ANP could be a useful biomarker for monitoring treatment response in hypertensive patients.
Circulating atrial natriuretic polypeptide in essential hypertension.Kohno, M., Yasunari, K., Matsuura, T., et al.[2019]
In a study involving 60 spontaneously hypertensive rats, MANP significantly reduced blood pressure and increased levels of cyclic guanosine monophosphate (cGMP), indicating its effectiveness as a potent activator of the pGC-A receptor.
When combined with furosemide, MANP not only enhanced the blood pressure-lowering effects but also reduced the increase in aldosterone production typically caused by furosemide, suggesting a beneficial role in managing hypertension and preserving renal function.
MANP (M-Atrial Natriuretic Peptide) Reduces Blood Pressure and Furosemide-Induced Increase in Aldosterone in Hypertension.Dzhoyashvili, NA., Iyer, SR., Chen, HH., et al.[2023]
In a study of 1,034 African Americans and 880 non-Hispanic whites, higher levels of MR-proANP in the blood were significantly linked to increased systolic blood pressure (SBP), pulse pressure, and severity of hypertension, indicating its potential role as a biomarker for hypertension.
The associations between MR-proANP levels and hypertension metrics were consistent across both ethnic groups, suggesting that MR-proANP could be a useful indicator of arterial stiffness and hypertension severity in diverse populations.
Plasma midregional pro-atrial natriuretic peptide is associated with blood pressure indices and hypertension severity in adults with hypertension.Khaleghi, M., Saleem, U., Morgenthaler, NG., et al.[2022]

Citations

Circulating atrial natriuretic polypeptide in essential hypertension. [2019]
MANP (M-Atrial Natriuretic Peptide) Reduces Blood Pressure and Furosemide-Induced Increase in Aldosterone in Hypertension. [2023]
Plasma midregional pro-atrial natriuretic peptide is associated with blood pressure indices and hypertension severity in adults with hypertension. [2022]
A novel atrial natriuretic peptide based therapeutic in experimental angiotensin II mediated acute hypertension. [2022]
Atrial natriuretic peptides in man. [2019]
A human atrial natriuretic peptide gene mutation reveals a novel peptide with enhanced blood pressure-lowering, renal-enhancing, and aldosterone-suppressing actions. [2022]
Effects of intravenously administered human atrial natriuretic peptide on elevated blood pressure during surgery. [2018]
Effects of Wild-Type and Mutant Forms of Atrial Natriuretic Peptide on Atrial Electrophysiology and Arrhythmogenesis. [2015]
The diagnostic performance of mid-regional portion of pro-atrial natriuretic peptide for the detection of left ventricular hypertrophy in Caucasian hypertensive patients. [2022]
Plasma levels of atrial natriuretic peptide are raised in essential hypertension during low and high sodium intake. [2019]
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