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Active Treatment: HU6 Planned doses of HU6; N = 31 for Heart Failure (HFpEF Trial)

Phase 2
Recruiting
Research Sponsored by Rivus Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult male or female, ≥40 years of age.
Competent to understand the information given in the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved Informed Consent Form (ICF) and must sign the form prior to the initiation of any study procedures.
Timeline
Screening 3 days
Treatment 4 months
Follow Up 14 days
Awards & highlights

HFpEF Trial Summary

This trial is testing a new drug (HU6) to see if it is safe and effective. People taking the drug will be compared to people taking a placebo.

Eligible Conditions
  • Heart Failure

HFpEF Trial Eligibility Criteria

Inclusion Criteria

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

HFpEF Trial Timeline

Screening ~ 3 days
Treatment ~ 4 months
Follow Up ~14 days
This trial's timeline: 3 days for screening, 4 months for treatment, and 14 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
Evaluate weight reduction while on HU6 treatment

Side effects data

From 2021 Phase 2 trial • 80 Patients • NCT04874233
42%
Flushing
32%
Diarrhoea
16%
Palpitations
16%
Night sweats
11%
Dizziness
11%
Abdominal Pain
5%
Nausea
5%
Myalgia
5%
Vessel puncture site haemorrhage
5%
Oropharyngeal pain
5%
Decreased appetite
5%
Presyncope
5%
Rhinitis
5%
Arthralgia
5%
Fatigue
5%
Dyspnoea
5%
Pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active: HU6 450mg
Active: HU6 150mg
Active: HU6 300mg
Placebo Comparator

HFpEF Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Treatment: HU6 Planned doses of HU6; N = 31Experimental Treatment1 Intervention
Group II: Placebo Comparator Non-active study drug N = 31Placebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HU6
2021
Completed Phase 2
~180

Find a Location

Who is running the clinical trial?

Rivus Pharmaceuticals, Inc.Lead Sponsor
7 Previous Clinical Trials
492 Total Patients Enrolled
Shaharyar Khan, PhDStudy DirectorRivus Pharmaceuticals, Inc.

Media Library

HU6 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05284617 — Phase 2
Heart Failure Research Study Groups: Placebo Comparator Non-active study drug N = 31, Active Treatment: HU6 Planned doses of HU6; N = 31
Heart Failure Clinical Trial 2023: HU6 Highlights & Side Effects. Trial Name: NCT05284617 — Phase 2
HU6 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05284617 — Phase 2
Heart Failure Patient Testimony for trial: Trial Name: NCT05284617 — Phase 2

Frequently Asked Questions

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

Is the enrollment window for this experiment currently ajar?

"As of today, the clinical trial is still open for participants. The study was first made available to prospective patients on September 30th 2022 and has been updated as recently as September 27th 2022."

Answered by AI

What is the size of the cohort engaged in this research?

"Affirmative, the publicly available information on clinicaltrials.gov states that this research trial is actively seeking participants. This initiative began recruiting on September 30th 2022 and was recently updated on September 27th 2022. The study requires 62 patients from 4 distinct sites to be accepted into the program."

Answered by AI

How widely dispersed is this trial across North America?

"There are 4 clinical sites that are taking part in this trial. These include Wake Forest located in Winston-Salem, University of Texas Southwestern situated in Dallas, and New Generation of Medical Research found near Hialeah; plus 1 other medical centre."

Answered by AI

Has the FDA authorized Active Treatment: HU6 Planned doses of HU6; N = 31 ?

"Our experts at Power gave Active Treatment: HU6 Planned doses of HU6; N = 31 a score of 2 due to its Phase 2 status, which implies that there is some data demonstrating safety but none for efficacy."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
New York
What site did they apply to?
Wake Forest
Weill Cornell Medicine
Northwestern University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0

What questions have other patients asked about this trial?

How long is the screening process. I noticed that the study is for diastolic heart failure, is there a study for cystolic heart failure?
PatientReceived no prior treatments

Why did patients apply to this trial?

Because I had a heart attack. I am just looking for possible future alternatives for the treatment of heart failure. Does this trial offer compensation?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Average response time
  • < 2 Days
Most responsive sites:
  1. Northwestern University: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for Subjects With Obese HFpEF
2022. "Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for Subjects With Obese HFpEF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05284617.
~26 spots leftby Apr 2025
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