Status:
COMPLETED
BLOCKade of Calcium Channels and Beta Adrenergic Receptors for the Treatment of Hypertension in HFpEF
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Julio Chirinos, MD, PhD
Raymond Townsend, MD
Conditions:
Heart Failure with Preserved Ejection Fraction
Hypertension
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
Heart failure with preserved ejection fraction (HFpEF) is a critical public health problem. Heart failure (HF) affects over 5 million adults in the United States (US), and is a major source of morbidi...
Eligibility Criteria
Inclusion
- Adults age 18-90 years
- Diagnosis of hypertension defined by at least two of the following: A) ICD-9 (401.0-404.91) or ICD-10 (I10-I13) codes signifying hypertension; B) Treatment with antihypertensive medication other than a loop diuretic for at least two months; C) History of previous blood pressure readings ≥130/80 mmHg at two separate office visits
- Stable antihypertensive therapy; defined as no changes in antihypertensive medications in the preceding 30 days
- A diagnosis of heart failure
- LV ejection fraction \>50%
- Elevated filling pressures defined by at least one of the following criteria: A) Mitral E/e' ratio (lateral or septal) \>8 with low e' velocity (septal e' \<7 cm/s or lateral e' \<10 cm/s) and at least one of the following: a. Enlarged left atrium (LA volume index \>34 ml/m2); b. Chronic loop diuretic use for management of symptoms; c. Elevated natriuretic peptides (BNP levels \>100 ng/L or NT-proBNP levels \>300 ng/L); B) Mitral E/e' ratio (lateral or septal) \>14; C) Previously elevated invasively determined filling pressures based on one of the following criteria: a. Resting LVEDP \>16 mmHg; b. Mean PCWP \>12 mmHg; c. PCWP or LVEDP ≥25 mmHg with exercise; D) Previous acutely decompensated heart failure requiring IV diuretics;
Exclusion
- Systolic BP meeting any of the following criteria: A) Current office systolic BP \<100 mmHg; B) Current office systolic BP 100-119 mmHg if not receiving treatment with an antihypertensive agent or if holding antihypertensive medication prior to randomization would be clinically contraindicated, as per the investigator's clinical judgement; C) Current office systolic BP ≥180 mmHg if not receiving treatment with a CCB or β-blocker, or ≥160 mmHg if already receiving a CCB and/or β-blocker prior to the pre-randomization wash-out period; D) Orthostatic hypotension defined as \>20 mmHg decline in office systolic BP 3-5 minutes following the transition from sitting to standing position
- Resting heart rate \<50 or \>100 bpm
- Contraindication to withholding CCB or β-blocker therapy (e.g. use of non-dihydropyridine CCB \[diltiazem or verapamil\] or β-blocker for rate control for atrial fibrillation) as per the investigator's clinical judgement
- Children, fetuses, neonates, prisoners, and pregnant women (women of childbearing age will undergo a pregnancy test during the screening visit) are not included in this research study.
- Inability/unwillingness to exercise
- Any the following echocardiographic findings: A) LV ejection fraction \<45% on any prior echocardiogram, unless it was in the setting of uncontrolled atrial fibrillation; B) Hypertrophic, infiltrative, or inflammatory cardiomyopathy; C) Clinically significant pericardial disease, as per investigator judgment; D) Moderate or greater left-sided valvular disease, any degree of mitral stenosis, or prosthetic mitral valve; E) Severe right-sided valvular disease; F) Severe right ventricular dysfunction
- Active coronary artery disease, defined as any of the following: A) Acute coronary syndrome or coronary intervention in the past 2 months; B) Ischemia on stress testing without either subsequent revascularization or a subsequent angiogram demonstrating the absence of clinically significant epicardial coronary artery disease, as per investigator judgement
- Clinically significant lung disease, defined as any of the following: A) Chronic Obstructive Pulmonary Disease meeting GOLD criteria stage III or greater; B) Treatment with oral steroids within the past 6 months for an exacerbation of obstructive lung disease; C) The use of daytime supplemental oxygen
- Primary pulmonary arteriopathy
- eGFR \<30 mL/min/1.73m2
- Any medical condition that, under the investigator's discretion, will interfere with safe completion of the study or validity of the endpoint assessments
- Known history of an allergy or clinically significant sensitivity (as determined by the investigator) to either amlodipine besylate or metoprolol succinate
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04434664
Start Date
December 1 2021
End Date
December 20 2024
Last Update
January 9 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104