Efficacy and Safety of a Quadruple Ultra-low-dose Treatment for Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: QUARTET LDQT; Candesartan
Intervention description: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.; Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension; Blood Pressure

Summary:

      To investigate, in a double-blind randomized controlled trial, whether initiating treatment
      with ultra-low-dose quadruple-combination therapy ("LDQT") will lower office blood pressure
      more effectively, and with fewer side effects, compared to initiating standard dose
      monotherapy as per current guidelines in patients with hypertension.

      Primary hypothesis: A combination pill comprising four types of blood pressure lowering
      medications, each at one-quarter standard doses, will lower office blood pressure more
      effectively than initiating patients with standard dose monotherapy as per contemporary
      clinical practice guideline recommendations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults (≥18 years)

          -  Spanish or English speaker.

          -  Previous documentation within the past 24 months of hypertension or high blood
             pressure (SBP 130-179 mmHg or DBP 80-109 mmHg) from general practitioner, pharmacist
             or health care professional (e.g., medical assistant, physician or nurse).

          -  Either: 1) Untreated (automated) clinic SBP 140-179 or DBP 90-109 mmHg in the last 12
             weeks, OR 2) Monotherapy with clinic SBP 130-159 or DBP 85-99 mmHg in the last 12
             weeks.

          -  Either: 1) Treatment naïve, OR 2) Currently not on treatment (not take in last 4
             weeks), OR 3) Currently taking 1 BP lowering drug (ACE, ARB, CCB, thiazide- or
             thiazide-like diuretic, BB, MRA, alpha blocker) at any dose.

          -  Research grade blood pressure measurement (baseline mean) SBP>= 115 mmHg and DBP >= 60
             mmHg

        Exclusion Criteria:

          -  Known contraindication to candesartan, amlodipine, indapamide or bisoprolol.

          -  Previous diagnosis of coronary artery disease, stroke, or heart failure.

          -  Presence of significant proteinuria (based on 3+ proteinuria via spot urinalysis or
             >300mg/dL of proteinuria based on random urinary albumin-to-creatinine ratio testing
             of 300 mg/g)

          -  Evidence of secondary cause of hypertension e.g., renal artery stenosis; significant
             renal impairment (eGFR <50 ml/min/1.73 m2), raised serum potassium (above lab normal
             limit of 5.5 mEq/L).

          -  Women who are pregnant, breast feeding or of childbearing potential and are not using
             and do not plan to continue using medically acceptable form of contraception
             throughout the study (pharmacological or barrier methods).

          -  Concomitant illness, physical impairment or mental condition which in the opinion of
             the study team / primary care physician could interfere with the conduct of the study
             including outcome assessments.

          -  Participation in a concurrent interventional medical investigation or pharmacologic
             clinical trial. Patients in observational, natural history or epidemiological studies
             not involving an intervention are eligible.

          -  Participant's responsible primary care or other responsible physician believes it is
             not appropriate for participant to switch current monotherapy.

          -  Inability or unwillingness to provide written informed consent.

          -  Unable to complete study procedures.