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Completed

NCT Number: NCT03350737

Coronary Arteriogenetic Heparinized Exercise

This study evaluates the addition of heparin to a 2-week cycle of physical rehabilitation in the treatment of refractory angina. Half of the patients will undergo heparin-primed physical rehabilitation, while the other half will undergo only physical rehabilitation.

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Key information

Conditions

Refractory Angina Angina Pectoris Angina, Stable Cardiovascular Diseases Chest Pain Chronic Stable Angina Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Centre of Serbia

Belgrade, 11000, Serbia

About this study

Our approach is based on the combination of pharmacological stimuli (with heparin) on top of a 2-week cycle of physical rehabilitation. The rationale for this chemical-physical cocktail stems from the fact that increase in shear stress (achieved with exercise), or heparin (when used alone) have no significant effect on coronary arteriogenesis. Nevertheless, when the two stimuli are coupled coronary arteriogenesis is consistently present, and clinically significant.

The basic principle of heparin treatment is to potentiates angiogenic growth factors, which are over expressed by increased shear stress at the site of pre-existing collateral vessels as a result of exercise or pacing. Although the precise mechanisms by which heparin potentiates arteriogenesis remain to be completely elucidated, heparin administration combined with exercise has great potential in treating patients with effort angina who are not indicated for conventional revascularization therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with documented coronary artery disease not amenable of future treatment and belonging to "no-option" category with symptoms consistent with angina pectoris

Exclusion criteria

  • Patients with unstable angina, recent myocardial infarction, uncontrolled hypertension, hemodynamically valvular heart disease, bronchial asthma, and neurologic and/or orthopedic illnesses that limit exercise capacity .
  • Patients receiving vitamin K antagonist.
  • Patients actively involved in programmes of cardiac rehabilitation or exercise training.

Treatment and study plan

Physical rehabilitation

Other

Standard treadmill exercise session

Other names: E

Heparin

Drug

Heparin i.v.

Other names: H

Placebo

Other

Sodium Chloride 0.9% i.v.

Other names: P

Primary outcomes

  1. Change from Baseline Canadian Cardiovascular Society (CCS) angina severity class at 2 weeks

    Time frame: 2 weeks

    CCS class ranging from 1 (mild) to 4 (severe) before and after the 2-week physical rehabilitation.

Secondary outcomes

  1. Change from Baseline peak stress wall motion score index (WMSI) at 2 weeks

    Time frame: 2 weeks

    Peak WMSI at stress echocardiography before and after 2-week physical rehabilitation at . Wall motion score index is assessed by using 17- segment model of left ventricle (1=normal, 4=dyskinetic).

  2. Change from baseline peak stress global longitudinal strain (GLS) at 2 weeks

    Time frame: 2 weeks

    Peak stress GLS assessed by echocardiography before and after the 2-week physical rehabilitation.

Other outcomes

  1. Change from Baseline Coronary Collateral Circulation (CCC) at 2 weeks

    Time frame: 2 weeks

    CCC score assessed by multi dimensional computed tomography (CT) before and after 2-week physical rehabilitation. Distal filling of the epicardial segment is semiquantitatively classified by using a four-point scale according to patterns at coronary CT angiography (CTA) (0 = absence of distal filling; 1 = partial distal filling, with a length less than one-third of the segment; 2 = partial distal filling, with a length between one-third and two-thirds of the segment; 3 = complete or partial distal filling, with a length longer than two-thirds of the segment). A coronary CTA scores correspond fully to Rentrop classification (coronary CTA score of 0 or 1 to Rentrop 0 or 1, coronary CTA score of 2 or 3 to Rentrop 2 or 3). Coronary CTA score of 3 is indicative of well-developed collaterals, contrary to scores of 0-2 (poorly developed). Also we look for change in growth of baseline bridging antegrade collaterals at 2 weeks (0= not present, 1= present)

  2. Change from Baseline Stable Angina questionnaire (SAQ) at 4 weeks

    Time frame: 2 weeks to one month

    19-item Seattle SAQ that assesses angina frequency, angina stability, physical limitations, treatment satisfaction, and disease perception/QoL

Sponsors and collaborators

Lead sponsor

Clinical Centre of Serbia

Other

Collaborators

  • Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Registry information

Official study title

Coronary ARteriogenesis With Combined Heparin and EXercise Therapy in Chronic Refractory Angina

Acronym: CARHEXA

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Nov 22, 2017
Registry last updated
May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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