A Study of Blood Pressure Control During Cancer Treatment

A Study of Blood Pressure Control During Cancer Treatment

Experimental: higher dose antihypertensive medications
Patients randomized to intensive SBP control will be treated to achieve an SBP goal <120 mm Hg, and patients randomized to standard SBP control will be treated to achieve an SBP goal <140 mm Hg. Antihypertensive medications will be titrated on the basis of seated blood pressure measurements obtained after a 5-min rest period. All participants will be provided with dietary (e.g., 1500mg/d sodium restriction) and lifestyle recommendations as background therapy for optimizing HTN control.
Other: antihypertensive medications

One or more of the following medications may be used in both randomization groups to achieve SBP goals:

Angiotensin converting enzyme inhibitors (ACEI)
Angiotensin receptor blockers (ARBs)
Beta-blockers (BB)
Thiazide-type diuretics
Calcium channel blockers
Aldosterone antagonists
Alpha1-receptor blockers.
Direct vasodilators
Loop diuretics

Diagnostic Test: Blood pressure measurement
Home BP Monitoring (HBPM)-Throughout the study period, patients will perform HBPM at baseline, month 6, and month 12 (end of treatment). At each of these timepoints, HBPM will be performed for 7 days with 2 morning and 2 evening readings for each day (measured 1-min part).
Diagnostic Test: Echocardiogram
At baseline, month 6, and month 12
Other: Symptom-limited cardiopulmonary exercise test
Consecutive patients in each treatment group who meet the eligibility criteria for exercise testing will be offered to participate in CPET at the time of consent. Patients who agree will undergo CPET (baseline, 6 months, and 12 months) until the target accrual of 33 patients per group is met.
Other: Quality of Life Measures
FACT-B, Fatigue Symptom Inventory (FSI), Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale, Godin Leisure Time Exercise Questionnaire (GLTEQ),PROMIS Medication Adherence Scale. Given baseline, 3 months and 12 months.
Diagnostic Test: Biomarkers
Research blood samples will be collected at baseline, 3 months, and 6 months

Source: View full study details on ClinicalTrials.gov

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September 6, 2023Comments OffCardiology | Cardiology Clinical Trials | Cardiology Studies | ClinicalTrials.gov | Drug Trials Near Me | US National Library of Medicine
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