Efficacy Study of Cardizem in Pulmonary Arterial Hypertension

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01645826
• Date of registration: 18/10/2011
• Prospective Registration: Yes
• Primary sponsor: University of South Florida
• Public title: Efficacy Study of Cardizem in Pulmonary Arterial Hypertension
• Scientific title: Calcium Channel Blockers in Nitric Oxide Non-responder Pulmonary Arterial Hypertension.
• Date of first enrolment: July 2012
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT01645826
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Mark Rumbak, MD
• Affiliation: University of South Florida

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult participants

- Confirmed WHO class I pulmonary arterial hypertension

- Nitric Oxide Non-Responders on right heart catheterization

- Experience dyspnea, NYHA III-IV with poor oxygenation and quality of life despite
standard treatments

- Must be able to swallow medications

Exclusion Criteria:

- Pulmonary hypertension secondary to 1) elevations in pulmonary venous pressures (i.e.
left heart disease), 2) chronic hypoxemic states from lung diseases such as COPD,
sleep-disordered breathing, alveolar hypoventilation disorders, chronic exposure to
high altitude and developmental abnormalities 3) chronic thromboembolic disease, 4)
sarcoidosis, 5) Lymphangiomyomatosis, 5) Pulmonary Langerhans Cell Histiocytosis

- Already on a calcium channel blocker

- Systolic blood pressure less than 90

- Heart rate less than 55

- Pregnant

- Cannot sign informed consent

- Right heart failure

- Pulmonary Veno-occlusive disease



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Familial Primary Pulmonary Hypertension

Primary Pulmonary Hypertension

Idiopathic Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension

Intervention(s)

Drug: Sugar Pill

Drug: Diltiazem Hydrochloride

Primary Outcome(s)

Six Minute Walk Distance [Time Frame: 12 weeks]

Secondary Outcome(s)

Quality of Life Score [Time Frame: 12 weeks]

Dyspnea Score [Time Frame: 12 weeks]

Pulse Oximetry [Time Frame: 12 weeks]

Secondary ID(s)

Pro00004379

Source(s) of Monetary Support

Please refer to primary and secondary sponsors