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Calcium Channel Blocker

Calcium Channel Blocker + Beta Blocker for Heart Failure (BLOCK HFpEF Trial)

Phase 4
Recruiting
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A diagnosis of heart failure
Adults age 18-90 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at the end of each of the two 4-week intervention phases
Awards & highlights

BLOCK HFpEF Trial Summary

This trial is investigating whether or not calcium channel blockers and beta blockers, two common types of blood pressure medication, are effective in treating heart failure with preserved ejection fraction.

Who is the study for?
This trial is for adults aged 18-90 with stable high blood pressure treatment, diagnosed heart failure, specific elevated heart pressures, and a history of hypertension. They must have a normal left ventricular ejection fraction (>50%). Excluded are those with certain blood pressure levels, severe lung disease or coronary artery disease, allergies to the drugs tested, kidney issues (eGFR <30), or conditions affecting study participation.Check my eligibility
What is being tested?
The trial investigates how two common blood pressure medications—Amlodipine Besylate (a calcium channel blocker) and Metoprolol Succinate (a beta-blocker)—impact heart function in patients with HFpEF. It aims to understand which medication better targets the physiological abnormalities associated with this type of heart failure.See study design
What are the potential side effects?
Potential side effects include dizziness due to low blood pressure from Amlodipine Besylate and fatigue or shortness of breath from Metoprolol Succinate. Both drugs may cause swelling in the limbs and irregular heartbeat; individual reactions can vary.

BLOCK HFpEF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with heart failure.
Select...
I am between 18 and 90 years old.

BLOCK HFpEF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at the end of each of the two 4-week intervention phases
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at the end of each of the two 4-week intervention phases 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 home systolic blood pressure
Secondary outcome measures
Change in arterial wave reflections
Change in home diastolic blood pressure
Change in large artery stiffness
+6 more

BLOCK HFpEF Trial Design

2Treatment groups
Active Control
Group I: Metoprolol succinateActive Control1 Intervention
Initial dose 100mg (1 capsule) daily, titrated up to 200mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use
Group II: Amlodipine besylateActive Control1 Intervention
Initial dose 5mg (1 capsule) daily, titrated up to 10mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,159 Total Patients Enrolled
42 Trials studying Heart Failure
7,464 Patients Enrolled for Heart Failure
Julio Chirinos, MD, PhDUNKNOWN
Raymond Townsend, MDUNKNOWN

Media Library

Amlodipine Besylate (Calcium Channel Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT04434664 — Phase 4
Heart Failure Research Study Groups: Metoprolol succinate, Amlodipine besylate
Heart Failure Clinical Trial 2023: Amlodipine Besylate Highlights & Side Effects. Trial Name: NCT04434664 — Phase 4
Amlodipine Besylate (Calcium Channel Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04434664 — Phase 4

Frequently Asked Questions

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

How is Metoprolol succinate typically deployed in medical treatments?

"Metoprolol succinate is a medicine suitable for treating high cardiovascular risk, myocardial infarction, hemodynamically stable states, and cases where dietary modifications have been unsuccessful."

Answered by AI

Has Metoprolol succinate been verified by the FDA?

"Metoprolol succinate has already been approved and therefore merits a score of 3 due to its established safety profile."

Answered by AI

Are there any opportunities currently available for individuals to join this research?

"According to clinicaltrials.gov, this investigation is actively recruiting participants and was originally posted on May 1st 2021 before being modified most recently on August 15th 2022."

Answered by AI

Who is eligible to take part in this clinical research endeavor?

"Eligible candidates must possess a diagnosis of hypertension and be within the age range of 18 to 90 years old. Approximately 50 individuals are being recruited for this medical trial."

Answered by AI

Does this experiment encompass participants aged 75 and above?

"Eligibility for this medical experiment mandates that participants are aged between 18 and 90 years. 79 studies were conducted with younger people while 1370 research projects focused on those over 65."

Answered by AI

Has Metoprolol succinate previously been administered in any other clinical experiments?

"Currently, there are 49 Metoprolol succinate studies in operation with 10 of them being Phase 3. Although numerous trials for this drug occur in Hackensack, New jersey, it is also available at 461 different medical centres."

Answered by AI

How many individuals are being granted access to this clinical experiment?

"Affirmative. According to the records on clinicaltrials.gov, this experiment is currently seeking participants since its inception in May 2021. It was last updated on August 15th, 2022 and requires 50 volunteers from a single medical site."

Answered by AI

Who else is applying?

What site did they apply to?
Hospital of the University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
~6 spots leftby Oct 2024